BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 DR

    MDR report key: 1072220 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00311
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 7, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SDR303 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 5594 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD